Use of Vagitories Based on St. John's Wort, Tea Tree Oil and Shepherd's Purse in the Treatment of Vaginal Inflammation

There are more and more herbal preparations that are used for the purpose of treatment and improvement of the clinical picture of vaginitis by patients themselves, but also by healthcare professionals. Plant species, St. John's wort, chamomile, calendula, yarrow, shepherd's purse and tea tree oil are well known for there anti-inflammatory, antimicrobial and wound healing activity. This paper presents the results of a clinical study in which three herbal formulations/vagitories, based on extracts of above mentioned plant species, were investigated for their effectiveness on non-specific vaginitis.

This was randomized controlled clinical study that included 210 women with diagnosed non-specific vaginitis. Patients were divided into two basic groups, women in reproductive stage and postmenopausal stage. Three subgroups, containing approximately 30 patients each, received one of three vagitorie formulations for 5 days during which the effects on subjective and objective symptoms were monitored.

Study Overview

• Status: Completed
• Conditions: Non Specific Vaginitis
• Intervention / Treatment: Drug: Shepherd's Purse extractum oleosum vagitories; Drug: Tea tree oil vagitories; Drug: Hyperici extractum oleosum vagitories; Drug: Vagitories - Probiotic

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 4

Contacts and Locations

Study Locations

• Bosnia and Herzegovina
  • Canton Sarajevo
    • Sarajevo, Canton Sarajevo, Bosnia and Herzegovina, 71000
      • Kemal Duric

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• adult women who already had sexual intercourse
• diagnosis of non-specific vaginal inflammation by medical examination.

Exclusion Criteria:

• microbiologically confirmed bacterial vaginosis,
• treatment with antibiotic therapy according to official protocols and guidelines
• allergies to one of the plant species included in the vaginal test,
• diabetes mellitus,
• pregnancy,
• lactation,
• immunodeficiency disorder,
• severe chronic illness,
• previous radiotherapy, chemotherapy and biological therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shepherd's Purse extractum oleosum vagitories; Vagitories containing Calendulae extractum oleosum 5,5% (w/w), Bursae pastoris extractum oleosum 5,5% (w/w), Matricariae extractum oleosum 5,5% (w/w), Hyperici extractum oleosum 5,5% (w/w) and Millefolii extractum oleosum 5,5% (w/w) as active component	Drug: Shepherd's Purse extractum oleosum vagitories; Shepherd's Purse extractum oleosum vagitories will be administered once daily for 5 days
Experimental: Tea tree oil vagitories; Vagitories containing tea tree oil, 200 mg per each vagitorie as active component	Drug: Tea tree oil vagitories; Tea tree oil vagitories will be administered once daily for 5 days
Experimental: Hyperici extractum oleosum vagitories; Vagitories containing Hyperici extractum oleosum 32% (w/w) as active component	Drug: Hyperici extractum oleosum vagitories; Hyperici extractum oleosum vagitories will be administered once daily for 5 days
Active Comparator: Vagitories - Probiotic; Commercially available vagitories with probiotic	Drug: Vagitories - Probiotic; Vagitories - Probiotic will be administered once daily for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in objective symptoms of non-specific vaginitis, assessed by gynecological examination	The clinical symptoms and signs, including redness, hyper-secretion, local edema, pain and annealing were diagnosed at the baseline and 5 days after the beginning of the treatment. Gynecologist determined only the presence or absence of the above mentioned symptoms.	1 day after treatment completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in subjective symptoms of non-specific vaginitis, assessed by the valuation of subjective parameter of vaginitis reported by patients during gynecological examination	Subjective symptoms including vaginal secretion, itching and dryness of the vaginal mucous were diagnosed at the baseline and 5 days after beginning of the treatment. During anamnesis gynecologist determined the presence or absence of the above mentioned symptoms.	1 day after treatment completion
Incidence of vaginitis correlated with age, life habits and sexual behavior, assessed by questioner	At the baseline, the patents completed a questionnaire that included questions regarding their age, life habits (permanent relationship, smoker, use of alcohol,number of births, abortion number) and sexual behavior (number of partners, years of first sexual intercourse, contraceptive use, previous presence of sexually transmitted diseases). The incidence of vaginitis correlated to above mentioned demographic data will be assessed by questioner	Through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: University of Sarajevo
• Collaborators: Institution for Health Protection of Women and Motherhood; University of Tuzla
• Investigators: Study Chair: Fahir Becic, PhD, Universiyt of Sarajevo Faculty of Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2019
• Primary Completion (Actual): June 21, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 17, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginal Diseases; Inflammation; Vaginitis; Vaginosis, Bacterial; Anti-Infective Agents, Local; Anti-Infective Agents; Tea Tree Oil
• Other Study ID Numbers: 03/7-1053/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No